Experience

Wooshin Lapache

• Slovenia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Specialist

  • Mar 2022 - Present

  𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 - ❖ Handling Change control, Non-conformance and CAPA’s ❖ Equipment Qualification, Area Qualification ❖ Review of Batch records, calibration reports and Analytical reports. ❖ Performing Internal Audits ❖ Annual Product Quality Review preparation ❖ Quality Management Review report preparation ❖ Cleaning validation management ❖ Review of Annual schedules pertaining to Qualification, calibration and maintenance and prepare monthly checks ❖ Performing Internal training. Show less



WOOSHIN labottach

• South Korea
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Specialist

  • Nov 2021 - Feb 2022

  𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 - ❖ Handling Change control, Non-conformance and CAPA’s ❖ Performing Internal Audit 𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 - ❖ Handling Change control, Non-conformance and CAPA’s ❖ Performing Internal Audit



AUROBINDO PHARMA LTD

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Senior Executive

  • Feb 2018 - Oct 2021

  𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Monitoring IPQA activities in, Dispensing, Granulation, Compression, Coating, Inspection, Primary Packaging and Secondary Packaging areas.❖ Carried out Process and Packaging validation activities.❖ Data entry and data analysis of Live Line Clearance activities.❖ Root cause analysis for non-conformances and complaints.

• Quality Assurance Executive

  • May 2017 - Jan 2018



Fourrts (India) Laboratories Pvt Ltd

• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Quality Assurance Officer

  • May 2014 - May 2016

  𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 - ❖ Monitoring IPQA activities in, Dispensing, Granulation, Compression, Coating, Inspection, Primary Packaging and Secondary Packaging areas. ❖ Carried out Process and Packaging validation activities. ❖ Equipment Qualification, Area Qualification ❖ Review of Batch records, calibration reports and Analytical reports. 𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 - ❖ Monitoring IPQA activities in, Dispensing, Granulation, Compression, Coating, Inspection, Primary Packaging and Secondary Packaging areas. ❖ Carried out Process and Packaging validation activities. ❖ Equipment Qualification, Area Qualification ❖ Review of Batch records, calibration reports and Analytical reports.